GlaxoSmithKline and partner Human Genome get US FDA priority review for Benlysta; GSK ups stake in Chinese vaccines JV

The US Food and Drug Administration has granted priority review designation to Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). The drug is being developed by UK giant GlaxoSmithKline (GSK; LN) and US partner Human Genome Sciences (HGSI).

A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists and, in the case of SLE, no new therapeutic has been approved for more than 50 years The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010.

The Biologics License Application for belimumab was submitted to the FDA on June 9 (The Pharma Letter June 11), and includes the results of two pivotal Phase III clinical trials that treated a total of 1,684 autoantibody-positive patients with SLE. HGS designed the Phase III program for belimumab in collaboration with GSK and leading international SLE experts, and in consultation with the FDA.